New drug approvals - Jan 2021

  • Please click here for a list of summary reports of benefit-risk assessments. 

Product Name

SONAZOID POWDER AND SOLVENT FOR DISPERSION FOR INJECTION 16 MICROLITRE PER VIAL

Active Ingredient

Perfluorobutane (microbubbles)

Application type

NDA-1

Product Registrant

GE HEALTHCARE PTE. LTD.

Date of Approval

06/01/2021

Registration No.

SIN16077P

Indications:

This medicinal product is for diagnostic use only. Sonazoid is an ultrasound contrast agent for use in vascular phase and Kupffer phase for ultrasonic imaging of focal hepatic lesions.

 

Product Name

SHINGRIX POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 50MCG/0.5ML

Active Ingredient

[Antigen] Recombinant Varicella Zoster Virus glycoprotein E (gE)

Application type

NDA-1

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

12/01/2021

Registration No.

SIN16079P

Indications:

Shingrix is indicated for the prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older (see Pharmacodynamics).

The vaccine’s effect on the prevention of PHN can be attributed to the effect of the vaccine on the prevention of HZ.

The use of Shingrix should be based on official recommendations.

 

Product Name

IDACIO SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML

IDACIO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.8ML

IDACIO SOLUTION FOR INJECTION FOR PAEDIATRIC USE 40MG/0.8ML VIAL

Active Ingredient

Adalimumab

Application type

NDA-2

Product Registrant

FRESENIUS KABI (SINGAPORE) PTE LTD

Date of Approval

25/01/2021

Registration No.

SIN16083P

SIN16084P

SIN16085P

Indications:

ADULTS

Rheumatoid Arthritis

IDACIO is indicated for reducing signs and symptoms and inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. IDACIO can be used alone or in combination with methotrexate or other DMARDs.

IDACIO, in combination with MTX, can also be used in the treatment of patients with recently diagnosed moderate to severely active rheumatoid arthritis who have not received methotrexate.

Psoriatic Arthritis

IDACIO is indicated for reducing signs and symptoms of active arthritis in adult patients with moderate to severe psoriatic arthritis when the response to previous DMARD therapy has been inadequate. IDACIO has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

IDACIO can be used alone or in combination with DMARDs.

Ankylosing Spondylitis

IDACIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Crohn’s Disease

IDACIO is indicated for the treatment of moderate to severe active Crohn’s disease in adults to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies, or who have lost response to or are intolerant of infliximab. For induction treatment, IDACIO should be given in combination with corticosteroids. IDACIO can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate.

Ulcerative Colitis

IDACIO is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Plaque Psoriasis

IDACIO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate.

Hidradenitis Suppurativa

IDACIO is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.

Uveitis

IDACIO is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

PEDIATRICS

Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

IDACIO in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA), in patients 2 years of age and older, who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDS). IDACIO can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see CLINICAL STUDIES). IDACIO has not been studied in patients aged less than 2 years.

Enthesitis-Related Arthritis

IDACIO is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.

Pediatric Crohn's Disease

IDACIO is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients, 6 years of age and older, with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.

Pediatric Plaque Psoriasis

IDACIO is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Adolescent Hidradenitis Suppurativa

IDACIO is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy.

Pediatric Uveitis

IDACIO is indicated for the treatment of chronic non-infectious anterior uveitis in pediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

 

Product Name

ROZLYTREK HARD CAPSULES 100MG AND 200MG

Active Ingredient

Entrectinib

Application type

NDA-1,3

Product Registrant

ROCHE SINGAPORE PTE LTD

Date of Approval

27/01/2021

Registration No.

SIN16086P, SIN16087P

Indications:

Solid tumors

Rozlytrek is indicated for the treatment of adult and pediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors without a known acquired resistance mutation, that are locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have progressed following prior therapies or have no satisfactory alternative treatments.

Non-small cell lung cancer (NSCLC)

Rozlytrek is indicated for the treatment of adult patients with ROS-1 positive, locally advanced or metastatic NSCLC. 

 

Product Name

XOSPATA® FILM-COATED TABLETS 40 MG

Active Ingredient

Gilteritinib

Application type

NDA-1

Product Registrant

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Date of Approval

28/01/2021

Registration No.

SIN16088P

Indications:

Xospata® (gilteritinib tablets) is indicated for:

  • the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation.

A validated test is required to confirm the FLT3 mutation status of AML.

 

Product Name

CLARITYN SYRUP 5 MG/5 ML (GRAPE FLAVOR)

Active Ingredient

Loratadine

Application type

NDA-2

Product Registrant

BAYER (SOUTH EAST ASIA) PTE LTD

Date of Approval

29/1/2021

Registration No.

SIN16091P

Indications:

Clarityn® is indicated for the fast, non-drowsy, 24 hours relief of symptoms associated with allergic rhinitis, such as sneezing, runny or itchy nose and burning or itchy eyes. Clarityn ® may also be used to help relieve symptoms of urticaria (itching, redness and number and size of hives).


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Published:

New Drug Approvals